Pharmycron Service GmbH

Analytics

We have our own modern analytical laboratory, where your product can undergo the appropriate tests.

Identity check and evidence of successful cleaning:

We check the identity of the products by means of IR-analytics on modern equipment.

Furthermore, UV-vis measuring serves as evidence of the success of the cleaning by the equipment. By means of a test of First-Rinse and Last-Rinse the cleaning success is documented and proven, in order to exclude cross-contamination.

Particle size analytics:

Thanks to our newest generation Malvern Master-Sizer the particle size distribution (PSD) is controlled by laser. For the incoming products this serves to determine the outgoing particle size for finding the parameters for milling, or micronization. Furthermore, the milling process is monitored by in-process controls (IPC) and finally the completely processed products are controlled.

The evaluation and determination of the size of the particles is done by means of distribution density curves (PSD-curves). The measurement of the micronized goods is part of the standard documentation, which after conclusion of the manufacture shall be made available to you.

This can naturally also take place in the course of a validation.

Further analytics:

Though our network that has been built up over the years we are able to offer many additional laboratory services, from checking for water content to determination of contents to a complete stability test programme tested over many years. Please contact us with any enquiries.